Going shopping for PrEP in Germany and elsewhere - no market for TruvadaÂ®?
I am a fairly rich guy from one of the richest countries in the world, so this logic should not concern me. I am a physician by training, so if I go to a pharmacy, I show my physician ID and go shopping without prescription. If I do that for my own wellness or health, I have to pay the official market price, which is legally defined in a major part (value added tax, compulsory rebate, fixed fees for wholesalers and pharmacists). I usually show my license card, ask for the price, cheaper alternatives, agree and pay.
My expenses on treatment of my diseases are usually covered by my health insurance (everyone living in Germany must be health insured, 90% are insured by statutory - not private - health insurers). In order to get the medication covered by my insurer, I have to see a statutory physician, get a formal prescription and then go to the pharmacy. This added loop enables my insurer to claim any further rebates from the medicineâ€™s producer. These rebates are individually negotiated by more than 100 statutory insurers in Germany; more than 15,000 confidential agreements exist between insurers and industry in this closed market. The overall annual growth rate of insurance spending on pharmaceuticals is budgeted on a federal and state level. It is well above the inflation rate.
I donâ€™t feel much of all that when I collect my insurance prescription at the pharmacy. My co-payments are fixed to a certain price per package received. This has the unwanted effect that some medications come in daily packaging, which can raise co-payments considerably. However, my overall co-payments are limited to 1% of my net income (2% if you donâ€™t have a chronic disease). So, I should not complain.
I may even prefer to choose a particular brand of a drug. However, that may be costly. The statutory insurers mostly have contracts with providers of generics. They will only cover that part of the price that is â€śtheirsâ€ť. Meaning that whatever is the best price they can get for an active substance in a certain formulation - that is the amount they will cover. The pharmacist will charge the extra. Certain drugs are exempted from this broad â€śgenericalizationâ€ť.
Even if I want to reclaim my own private shopping from my health insurer, I have a right to ask for reimbursement. It would help if I had a private prescription. It is a different format to mark it as different from the prescriptions â€śautomaticallyâ€ť covered by the statutory health insurers. If I succeed with this individual request, I do not get reimbursed fully. The insurer will calculate how much he/she would have paid, and give me just that.
So much for the complex normality. Thatâ€™s all a different ball park for pre-exposure prophylaxis for HIV (PrEP), as I am writing this two weeks after approval of TruvadaÂ® for PrEP by the European authorities.
Germany, surely one of the largest markets for PrEP, is without any access to the drug through legal markets. For four years institutions have mostly been in sleep mode over PrEP. So, we are in a number of ways unPrEPared:
- the product information in German (leaflets have to be in verey package) is not available, yet. The Deutsche AIDS Gesellschaft (the national association of medical scientific bodies and clinical researchers) points out that this has to be the case. Without such a translation the drug combination must not be sold for the purpose.
- the institutions and commentators are not sure yet, how TruvadaÂ® (the only product registered in Germany) is to be handled by the national regulatory bodies. Or if such a â€śprivateâ€ť issue should receive any public consideration at all. The health ministry points to an ongoing process. The producer remains silent and â€śhands-offâ€ť.
- the current market price of 840,00 Euros for a package of 30 tablets is far to high for private consumption (at least for me). At any rate that would be as much as the rent that I pay for the place I live in (which is also home to my husband and zoological menagerie). Considerations on how to lower that price rapidly are unheard of. The question, if the new indication â€śPrEPâ€ť for TruvadaÂ® will mean a longer duration of the patent for that purpose remains unanswered.
- the strict German laws on direct imports of e-commerce for pharma compounds do not allow me to order drugs online freely. I can only order drugs registered for the German market. Branded drugs are protected in e-commerce - meaning that I may not legally order a generic alternative to a patented brand drug (it must be explained that there is no â€śtrue generic alternativeâ€ť to TruvadaÂ® as the trials leading to the recent approval on the European level were all done with branded drug).
So three weeks ago, when I visited India, I went shopping with my physicians licence. India is home to one of the most excellent and high quality private markets. The pharmacist confirmed sold me two packages of a combination drug with the same ingredients as TruvadaÂ® (the generic offered is registered for treatment of HIV-infection in India and other countries). For buying two instead of one package of 30 pills, I even got a rebate. Total cash order: 3,832.00 Indian Rupies (or roughly 55 Euros for 60 pills).
I checked through customs on my way home with my private medication. Up to three months of supply are considered to be allowed.
As a physician, I can only buy the branded drug in Germany, if I keep silent to the (e-)pharmacist about the intended purpose of using it for PrEP (how bizarre!). The price difference is explained to some degree in reference to other drugs for treating an already established HIV-infection.
On October 8th 2016 the European AIDS Treatment Group co-sponsors a debate on PrEP in Berlin. HIV im Fokus will bring together activists, officials, physicians and AIDS service organizations to discuss and to come to conclusions. The interest is immense and expectations are high that the participants will be able to find a way out of the current dilemmata.
Trying to stay legal in a clouded market. Give PrEP a Chance!